Quality Systems Specialist
14 hours ago
A Quality Systems Specialist is required to support the management and improvement of quality systems processes, ensuring EU and US regulatory compliance with relevant company standards and Good Manufacturing Practice (GMP).
Key Responsibilities:- Implement and monitor established policies and procedures for regulatory bodies in CAPA, Complaint, Post Market Surveillance, and Non-conformance Report (NCR).
- Provide advice according to established procedures on CAPA, Complaint, Post Market Surveillance, and NCR against external requirements of regulatory authorities (ISO13485, MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745, and 21 CFR Part 820) and local quality standards.
- Offer effective solutions/advice to design and manufacturing teams on established procedures to ensure products meet regulations.
- Provide reports to management for system performance monitoring.
- Review and authorise Quality Management System documentation and processes for compliance with quality procedures and applicable regulations.
- Identify and collaborate on changes to increase efficiency and/or effectivity while ensuring compliance with applicable regulations.
- Support and perform training throughout the company for awareness of Quality System requirements.
- Conduct internal and inter-company Quality System Audits in line with local and group objectives.
- Work in accordance with Company Quality Standards, procedures, and processes and comply with GDP and GMP requirements.
- A level or equivalent Science/Engineering/Quality qualification.
- Minimum 3 years' experience in QA/QS environment within medical device/pharmaceutical industry.
- Knowledge of ISO13485, MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745, FDA QSR Part 820.
- Computer literacy in MS Word, Excel, MRP, good communication skills, and record/documentation skills.
- Ability to work with minimal supervision, use initiative, and work with integrity, customer focus, accountability, and teamwork.
ATL Technology is a fast-growing provider of outsourced design, development, and manufacturing services to the medical device market. Our UK site (GML Medical Ltd - an ATL Technology owned Company) is based in St Mellons, Cardiff, UK.
We believe there is a better way to bring medical devices to market. We use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of life.' It is our mission to be the leading provider of custom engineered solutions for top medical device manufacturers.
ATL has operations in the UK, China, Costa Rica, Taiwan, UT-USA, plus remote staff in strategic global locations, and we're growing.
The successful candidate will receive a salary between £40,000 and £55,000 per annum, depending on experience.
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